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Pediatric non-clinical drug testing : principles, requirements, and practice /
"This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and ho...
| Clasificación: | Libro Electrónico |
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| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
John Wiley & Sons,
2012.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Pediatric Nonclinical Drug Testing; Contents; Preface; Acknowledgments; Contributors; 1. Introduction; 2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children; 3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing; 4. FDA Approach to Pediatric Testing; 5. Pediatric Drug Development Plans; 6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants; 7. Nonclinical Testing Procedures--Pharmacokinetics.
- 8. Preclinical Development of a Pharmaceutical Product for Children9. Juvenile Toxicity Study Design for the Rodent and Rabbit; 10. Dog Juvenile Toxicity; 11. Use of the Swine Pediatric Model; 12. Juvenile Immunodevelopment in Minipigs; 13. Use of Primate Pediatric Model; 14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective; Appendix 1 Maturation of Organ Systems in Various Species; Appendix 2 Sample Juvenile Toxicity Testing Protocol; Index.